Second SKYRIZI® Indication Approved

On January 21, 2022 the U.S. Food and Drug Administration (FDA) approved SKYRIZI® (risankizumab-rzaa), an interleukin-23 inhibitor, for the treatment of active psoriatic arthritis (PsA) in adults. [1]

This approval is based on findings from the KEEPsAKE-1 and KEEPsAKE-2 studies, which evaluated safety and efficacy among adult patients with PsA. In both Phase 3 studies, SKYRIZI® met the primary endpoint of ACR20 response at week 24 compared to placebo and demonstrated significant improvements across several other manifestations of PsA, including swollen, tender, and painful joints. [1]

The dosing regimen for SKYRIZI® is similar with to that for patients with moderate-to-severe psoriasis. It is a single 150 mg subcutaneous injection four times a year (after two starter doses at weeks 0 and 4) – and can be administered alone or in combination with DMARDs. [1]

Skyrizi is one of more than a dozen systemic agents approved by the FDA for the treatment of psoriatic disease. For more information on biologics, visit the NPF Biologics resources.